Recruiting

Observational Study

Sponsor:

Baylor College of Medicine

Code:

NCT06140810

Conditions

Heart Transplant Failure

Anesthesia

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Lung Recruitment

Study Details

Brief summary:

Following orthoptopic heart transplantation (OHT), children undergo surveillance cardiac catheterizations to assess for signs of rejection including muscle biopsy as well as pressure measurements to guide post transplant treatment regiments. These procedures are done under general anesthesia which promotes lung tissue collapse (atelectasis). What is not known is the effect of atelectasis on intracardiac pressures which are a critical area of monitoring post-transplant patients for rejection.

Conditions

Heart Transplant Failure

Anesthesia

Study ID

NCT06140810

Start date

Nov 20, 2023

Status verified date

Dec, 2023

Completion date

Nov 1, 2024

Anticipated

Primary completion date

Nov 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients having undergone orthotropic heart transplantation
  • Patients requiring routine heart catheterization for post-transplant surveillance
  • General anesthesia

Exclusion Criteria:

  • Patient/parental refusal
  • Patients with suspected or known acute rejection
  • Known anti-rejection medication non-compliance
  • Patients within 1 year following heart transplant
  • Home oxygen requirement
  • Previous lung surgery (e.g., lobectomy) other than biopsy
  • Lung transplantation
  • Known pulmonary fibrosis
  • Known pulmonary hypertension (>1/2 systemic)
  • Sedation without the use of an airway device
  • Active respiratory infection -Inability to provide recruitment breaths >25mmHg -Cardiomegaly
  • Recipient/donor size mismatch

Study Design

Enrollment

15 participants

Anticipated

Interventions and Outcome Measures

Arms

Right ventricular End diastolic pressure

Measurement of pre and post recruitment right ventricular end diastolic pressure

Interventions

Lung Recruitment

Lung Recruitment will be performed during general anesthesia to reduce areas of atelectasis

Primary outcome measure

  • Number of participants with reduction of right ventricular end diastolic pressure of 3mmHg or greater [ Time Frame: 10 minutes ]

Central Contacts and Locations

Central contacts

Adam Adler, MD

8328245800adam.adler@bcm.edu

Locations

Texas Childrens Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Adam Adler, MD

832-824-5800adam.adler@bcm.edu

More Information

Sponsor

Baylor College of Medicine

Last update posted

Dec 21, 2023

Last verified

Dec, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2023-12-21.